Decentralisation in clinical trials could boost representation for more diverse demographic groups, a study has found.

Research unveiled by the Tufts Center for the Study of Drug Development (CSDD) evaluated 69 clinical trials and found there were more ethnic groups and women enrolled in decentralised clinical trials (DCTs).

The study found that in studies with no decentralisation, 14.2% of trials enrolled Asian trial participants while DCTs saw 20.9% of enrolled patients from an Asian heritage. At the same time, participants who identified as Indigenous Americans were only enrolled in 0.5% of studies without any form of decentralisation while 1.9% of studies with decentralisation enrolled patients with this heritage.

At the same time, the number of women involved in DCTs was higher than men, with the DCT group seeing an average of 55% female participants, against 49%. However, the study saw only a minimal 0.3% increase in DCTs from enrolled participants identifying as black or of African descent.

Tufts CSDD executive director Ken Getz said: “The results show that DCT component use in clinical trials is associated with improvements in proportional representation by race and ethnicity but there is still wide variation in patient preferences, by disease condition, and by the type of DCT component deployed.”

DCTs provide several benefits, namely allowing for greater convenience for trial participants, especially when decentralisation means that clinical research organisations (CROs) can select sites closer to where communities live. Reducing travel times and burdens on patients has previously been identified as a key driver of patient participation in trials.

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During the pandemic, there was an uptick in DCTs however this spike has now plateaued. The Clinical Trials Arena’s DCT tracker uncovers key trends and players in the clinical trial decentralisation arena. A recent feature evaluated whether DCTs could assist in the research of Alzheimer’s disease.

The Partnership for the Advancement of Clinical Trials (PACT) Consortium, which spearheaded the research, is a collaborative group set up by a selection of sponsors, CROs, and biotechs to examine and promote virtual and remote solutions in clinical trial planning. Companies involved in the group include Medable, Novartis, and Roche Genentech among others.

Getz added: “Improvement in enrolment diversity and clinical trial access requires a very intentional and strategic approach. In a separate study, certain decentralised elements such as local labs, were associated with significantly higher proportional representation among black participants.

“As we collect more empirical evidence, it is very clear that one size does not fit all. Each clinical trial requires a custom approach driven by patient needs and preferences.”

Decentralisation and trial efficiency are consistently debated topics across the medical device industry, with companies looking to expand their capacity while keeping patients engaged. Industry stakeholders will be meeting for the Outsourcing Clinical Trials West Coast 2025 conference in San Francisco, US, on this theme.